Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 1:12 PM
NCT ID:
NCT03376659
Group ID:
EG000
Title:
Phase I - Safety
Description:
* MVA-BN-CV301 (prime) - Day 1 and Day 29.
* FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53.
* Durvalumab - q2 weeks
* Capecitabine - twice a day, Monday - Friday Weekly
* Bevacizumab - q2weeks (colorectal cancer patients only)
Durvalumab: 750mg IV q2 weeks
CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)
FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c.
Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly
Bevacizumab: 5mg/kg IV q2weeks
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
8
Other Number Affected:
8
Other Number At Risk:
8
Study:
NCT03376659
Results Section:
NCT03376659
Adverse Events Module:
NCT03376659